Thyroid Molecular Testing (VA-24-00051860)

NOTICE OF INTENT TO SOLE SOURCE NOTICE OF INTENT TO SOLE SOURCE This notice is being published in accordance with Federal Acquisition Regulation (FAR) Subpart 5.101 requiring dissemination of information for proposed contract actions. This is a notice of intent to award a sole source contract and is not a request for competitive quotes/proposals.

The Department of Veterans Affairs, Network Contracting Office (NCO) 07, Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA 30033 is issuing this Notice of Intent (NOI) to inform industry contractors of the Government s intent to execute a Sole Source requirement under FAR Part 13.5 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Only responsible Available Source and no other Supplies or Services will satisfy Agency requirement.

This notice satisfies the posting requirements at FAR Part 5.101. The intended contractor is Cyto Path Biopsy, Inc, 760 Westchester Ave, Rye Brook, NY 10573-1341 Place of performance is Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA 30033. This contractor is to provide service contract support services on the Thyroid Molecular Testing located at the Department of Veterans Affairs Medical Center in Decatur, GA (Atlanta VA Healthcare System).

Services shall be performed by Cytopath Biopsy Lab Inc, the exclusive manufacturer of ThroSeq v3 Genomic Classifier (GC). Period of Performance shall begin on 5/1/2024 to 4/31/2025 unless otherwise noted in this contract. Cytopath Biopsy Lab Inc does not currently have any authorization or certification process in place for companies performing the Thyroid Molecular Testing.

Cytopath Biopsy Lab Inc , LLC has confirmed that Cytopath Biopsy Lab Inc has the proprietary information for the ThyroSeqq v3 Genomic Classifier to meet the requirements for the Atlanta VAMC. .The Contractor shall provide the Atlanta VA with transport media for the FNA thyroid specimen and must provide packaging and postage label for overnight shipment. Turnaround time must be within seven (7) business days.

The Contractor facility shall be a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, undergoing regular proficiency surveys of their testing. The Contractor shall provide customer service that includes an expertise in thyroid testing panels, who shall be available Monday Friday between the hours of 8am 4:30pm, MST. The laboratory shall have an established and reputable history of performing thyroid molecular testing for other VA laboratories.

The molecular test used for evaluating indeterminate thyroid nodules shall have high specificity and sensitivity for malignancy, high predictive value, and shall employ an extensive panel of thyroid-related gene mutations for detection to include at a minimum: BRAF, RAS, TERT, RET, NTRK, and ALK. The test shall be able to use small biopsy samples and must accept frozen samples.

A report shall be provided with each sample that shall include detected mutations/alterations with interpretation (including percentage/possibility of malignancy). The North American Industry Classification System (NAICS) for this requirement is, 621511- Medical Laboratories (FSC) is Q301- Medical Laboratory Testing. The Small Business Administration (SBA) size standard for this sector is 41.5 million. This notice of intent is neither a formal solicitation nor a request for competitive proposals.

No solicitation document is available and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only.

Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government. All inquiries and concerns must be addressed in writing via e-mail to Earnest Ellison, earnest.ellison@va.gov with the following information referenced in the subject line, 36C247Q0480 Thyroid Molecular Testing.

All interested parties who are responsible, certified, and capable may identify their interest and may submit a capabilities statement no later than 12:00 PM Eastern Standard Time (EST) on March 22, 2024, to Earnest Ellison, earnest.ellison@va.gov . The interested parties bear full responsibility to ensure complete transmission and timely receipt.